Device Classification Name |
monitor, oxygen, cutaneous, for infant not under gas anesthesia
|
510(k) Number |
K860124 |
Device Name |
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING |
Applicant |
MENNEN MEDICAL, INC. |
10123 MAIN ST. |
CLARENCE,
NY
14031
|
|
Applicant Contact |
RONALD WIDMAN |
Correspondent |
MENNEN MEDICAL, INC. |
10123 MAIN ST. |
CLARENCE,
NY
14031
|
|
Correspondent Contact |
RONALD WIDMAN |
Regulation Number | 868.2500
|
Classification Product Code |
|
Date Received | 01/14/1986 |
Decision Date | 05/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|